NCT06754644 A Study to Evaluate Efficacy, and Safety of QL2107 Plus Chemo and Compare With Keytruda in Participants With IV nqNSCLC
| NCT ID | NCT06754644 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Qilu Pharmaceutical Co., Ltd. |
| Condition | NSCLC |
| Study Type | INTERVENTIONAL |
| Enrollment | 808 participants |
| Start Date | 2025-01-15 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 808 participants in total. It began in 2025-01-15 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The goal of this clinical trial is to compare the efficacy similarities between QL2107 and Keytruda in metastatic non-squamous NSCLC.
Eligibility Criteria
Inclusion Criteria: * Subjects who voluntarily participate, sign the Informed Consent Form (ICF), and are able to comply with the study procedures; * Subjects aged ≥ 18 and ≤ 75 years at enrollment, male or female; * Histologically or cytologically confirmed metastatic (stage IV) non-squamous NSCLC as per the American Joint Committee on Cancer (AJCC) 8th Edition; if multiple tumor histologies are present, the predominant cell type should be classified; * No EGFR sensitive mutations or ALK gene translocations. * Expected survival ≥ 3 months; * Eastern Cooperative Oncology Group (ECOG) performance status score: 0 or 1; Exclusion Criteria: * Pulmonary radiation therapy \> 30 Gy within 6 months prior to the first dose; * Palliative radiation therapy completed within 7 days prior to the first dose; * Any other form of anti-tumor therapy expected to be required during the study; * Uncontrolled or symptomatic pericardial effusion, pleural effusion and ascites requiring repeated paracentesis and drainage; * Presence of metastases to brain stem, meninges and spinal cord or compression;
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06754644 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying NSCLC. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06754644 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 808 participants.
Is NCT06754644 currently recruiting?
Yes, NCT06754644 is actively recruiting participants. Contact the research team at sdyujinming@126.com for enrollment information.
Where is the NCT06754644 trial being conducted?
This trial is being conducted at Jinan, China.
Who is sponsoring the NCT06754644 clinical trial?
NCT06754644 is sponsored by Qilu Pharmaceutical Co., Ltd.. The trial plans to enroll 808 participants.